Acute Coronary Syndrome
Conditions
Keywords
Statins, Contrast-Induced Acute Kidney Injury, Periprocedural Myocardial Damage
Brief summary
The aim of the project is to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury in patients with non-ST-elevation acute coronary syndromes scheduled for early invasive strategy.
Detailed description
This is a prospective, single-centre, randomized study, designed to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of Contrast Induced-Acute Kidney Injury (CI-AKI). Consecutive statin-naïve patients admitted in the investigators institution for non-ST elevation Acute Coronary Syndrome (NSTE-ACS) and scheduled for early invasive strategy will be eligible. Patients are randomized into two groups: 1) high-dose rosuvastatin (40 mg on-admission followed by 20 mg/day); 2) high-dose atorvastatin (80 mg on-admission followed by 40 mg/day). Randomization will be performed on-admission by computerized open-label assignment in blinded envelopes used in a consecutive fashion. All patients receive the standard pre-procedural hydration. The primary end-point is the proportion of patients with an increase in serum creatinine of ≥ 0.5 mg/dl or ≥ 25% above baseline within 72 hours after contrast medium administration. The secondary end-points are persistent worsening of renal damage (eGFR reduction \>= 25% at 30 days) and cumulative adverse clinical events at follow-up. Specifically: death, myocardial infarction, dialysis, stroke or persistent renal damage at 30 days; death or myocardial infarction at 6 and 12 months.
Interventions
DRUGRosuvastatin
DRUGAtorvastatin
Sponsors
Centro Cardiopatici Toscani
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All consecutive statin-naive patients with non ST-elevation acute coronary syndrome admitted to our institution and scheduled for early invasive strategy are considered for enrollment
Exclusion criteria
* Current statin treatment * High-risk features warranting emergency coronary angiography (within 2 hours) * Acute renal failure or end-stage renal failure requiring dialysis or serum creatinine ≥ 3 mg/dl * Severe comorbidities which precluded early invasive strategy * Contraindications to statin treatment * Contrast media administration within the last 10 days * Pregnancy * Refusal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast Induced-Acute Kidney Injury | 72 hours | Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal function at 30 days | 30 days after discharge | Estimation of the glomerular filtration rate in all patients at 30 days |
| Cardiovascular and renal outcome | 30 days, 6 months, 12 months | Composite cardiovascular and renal events at follow-up including acute renal failure requiring dialysis, persistent renal damage, all-causes mortality, myocardial infarction or stroke. |
| Anti-inflammatory effect of rosuvastatin and atorvastatin | On admission (baseline), at discharge (after 5 days) & at 30 days | High-sensitivity C-reactive protein (hs-CRP)will be measured on admission, at discharge and at 30 days. |
| Lipid-modulatory effects of atorvastatin and rosuvastatin | On admission (baseline), at discharge (after 5 days) & at 30 days | Low density lipoprotein (LDL) levels will be determined on admission, at discharge and at 30 days. |
| Myocardial Damage | During hospitalization (average 5 days) | Total cardiac biomarkers release during the index event |
Countries
Italy
Outcome results
None listed